VISTECH reviewed the requirements outlined by the company and researched industry best practices. Core to the IQMP was the ability to define and quantify decision making, and VISTECH added key domain expertise as it had experience with a well-known, standard decision analysis process. VISTECH worked with the company to design a process for identifying the appropriate IQMP for any unique trial by leading the user through questionnaires that collect clinical trial quality metrics to produce an overall weighted score, providing a single, easily visualized quality and risk indicator for each pivotal or non-pivotal trial. VISTECH created a web application that defined critical to quality risks, ranking them by failure modes and effects analysis. VISTECH automated the process of identifying those risks as well as prioritizing and isolating prevention and mitigation actions. The resulting solution allowed the appropriate specification limits for quality metrics to be identified, which ultimately eliminated manual practices, increasing organizational performance and reducing time-to-market.